NCT05846529

Brief Summary

This study aimed to evaluate the response rate and safety of oral thrombopoietin receptor agonist (Eltrombopag drug) used for children with chronic immune thrombocytopenia in patients attending Assiut university children's hospital.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

April 7, 2023

Last Update Submit

May 4, 2023

Conditions

Thrombopoietin Receptor Agonist

Outcome Measures

Primary Outcomes (1)

  • response to oral thrombopoietin receptor agonist

    assess haematological response to oral thrombopoietin receptor agonist (Eltrombopag) therapy

    baseline

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infants and children between age of (2 year to \<18 years old)

You may qualify if:

  • Subjects between 2 year and \<18 years of age in both sex
  • Confirmed diagnosis of chronic ITP
  • all patient received oral thrombopoietin receptor agonist (Eltrombopag) for 6 months or more

You may not qualify if:

  • age of the patient \< 2years and \>18 years
  • secondary thrombocytopenia
  • Concurrent or past malignant disease, including myeloproliferative disorder
  • patient with platelet agglutination abnormality that prevents reliable measurement of platelet counts
  • patient with bone marrow aplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kuter DJ. The structure, function, and clinical use of the thrombopoietin receptor agonist avatrombopag. Blood Rev. 2022 May;53:100909. doi: 10.1016/j.blre.2021.100909. Epub 2021 Nov 16.

    PMID: 34815110BACKGROUND

  • Jurczak W, Chojnowski K, Mayer J, Krawczyk K, Jamieson BD, Tian W, Allen LF. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018 Nov;183(3):479-490. doi: 10.1111/bjh.15573. Epub 2018 Sep 7.

    PMID: 30191972BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 6, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-04